CompletedNot Applicable

Post Approval Study of the AcrySof® IQ Toric Intraocular Lens (IOL) Models SN6AT6-SN6AT9

United States477 participantsStarted 2012-02

Plain-language summary

The purpose of this study is to evaluate the use of toric high cylinder power intraocular lenses in a larger population in clinical practice and assure the continued safety of these approved devices.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed with bilateral cataracts and in the targeted astigmatism range. * Planned cataract removal by phacoemulsification. * Pupil size greater than or equal to 6 mm after dilation. * Able to undergo second eye surgery within 30 days of first eye surgery. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Irregular corneal astigmatism. * Any inflammation or swelling of the cornea. * Any corneal abnormality other than regular corneal astigmatism. * Previous corneal refractive surgery. * Amblyopia. * Diabetic retinopathy. * Uncontrolled glaucoma. * Currently participating in another investigational drug or device study that may confound the results of this investigation. * Other protocol-defined exclusion criteria may apply.

What they're measuring

Rate of Severe Visual Distortions

Timeframe: 6 months

Trial details

NCT IDNCT01601665

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-07

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